title: Clinical evaluation of a resorbable wrap-around implant as an alternative to nerve repair: a prospective, assessor-blinded, randomised clinical study of sensory, motor and functional recovery after peripheral nerve repair.
abstract: Peripheral nerve injures are common and often result in impaired functional recovery. The majority of injuries involve the arm and/or the hand. The traditional treatment for peripheral nerve injuries is repair by using microsurgical techniques, either by primary nerve suture or nerve graft, but research to find more successful methods that could improve recovery is ongoing. Tubulisation has been investigated by several authors and is suggested as an alternative to microsurgical techniques. The resorbable poly[(R)-3-hydroxybutyrate] (PHB) is one of the materials that has been previously tested experimentally. In this prospective, randomised, assessor-blinded clinical study, PHB was investigated as an alternative to epineural suturing in the treatment of peripheral nerve injuries at the wrist/forearm level of the arm. Twelve patients, with a complete, common, sharp injury of the median and/or ulnar nerve at the wrist/forearm level, were treated by either using PHB or microsurgical epineural end-to-end suturing. All patients were assessed using a battery of tests, including evaluation of functional, sensory and motor recovery by means of clinical, neurophysiological, morphological and physiological evaluations at 2 weeks and 3, 6, 9, 12 and 18 months after surgery. No adverse events or complications considered as product related were reported, and thus PHB can be regarded as a safe alternative for microsurgical epineural suturing. The majority of the methods in the test battery showed no significant differences between the treatment groups, but one should consider that the study involved a limited number of patients and a high variability was reported for the evaluating techniques. However, sensory recovery, according to the British Medical Research Council score and parts of the manual muscle test, suggested that treating with PHB may be advantageous as compared to epineural suturing. This, however, should be confirmed by large-scale efficacy studies.
authors.affiliation: Department of Hand & Plastic Surgery, Umeå University SE-901 87 Umeå, Sweden. maria.aberg@astratech.com
authors.forename: Maria
authors.initials: M
authors.lastname: Aberg
authors.forename: Christina
authors.initials: C
authors.lastname: Ljungberg
authors.forename: Ellenor
authors.initials: E
authors.lastname: Edin
authors.forename: Helena
authors.initials: H
authors.lastname: Millqvist
authors.forename: Erik
authors.initials: E
authors.lastname: Nordh
authors.forename: Anna
authors.initials: A
authors.lastname: Theorin
authors.forename: Giorgio
authors.initials: G
authors.lastname: Terenghi
authors.forename: Mikael
authors.initials: M
authors.lastname: Wiberg
mesh_terms: D020155:3-Hydroxybutyric Acid / Q000494:pharmacology; D020341:Absorbable Implants; D000293:Adolescent; D000328:Adult; D004576:Electromyography; D005260:Female; D005500:Follow-Up Studies; D005543:Forearm Injuries / Q000150:complications / Q000175:diagnosis; D018737:Hand Strength; D006801:Humans; D008297:Male; D008475:Median Nerve / Q000293:injuries / Q000601:surgery*; D020423:Median Neuropathy / Q000209:etiology / Q000601:surgery*; D008866:Microsurgery / Q000379:methods; D008875:Middle Aged; D009048:Motor Skills / Q000502:physiology; D009416:Nerve Regeneration / Q000502:physiology*; D019635:Neurosurgical Procedures / Q000379:methods; D059348:Peripheral Nerve Injuries; D010525:Peripheral Nerves / Q000601:surgery; D000091402:Prohibitins; D011446:Prospective Studies; D019736:Prostheses and Implants; D019651:Plastic Surgery Procedures / Q000379:methods*; D020127:Recovery of Function; D012677:Sensation / Q000502:physiology; D016037:Single-Blind Method; D013997:Time Factors; D020424:Ulnar Neuropathies / Q000209:etiology / Q000601:surgery*; D014954:Wrist Injuries / Q000150:complications / Q000175:diagnosis; D055815:Young Adult
chemical_list: C000717328:PHB protein, human; D000091402:Prohibitins; D020155:3-Hydroxybutyric Acid